Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump
FDA 510(k) K013767 · Sterling Medivations, Inc.
510(k) numberK013767
Submission
- Device name
- Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump
- Applicant
- Sterling Medivations, Inc.
Los Altos Hills, CA, US - Received
- November 13, 2001
- Decision date
- December 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code FRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K021530 | Simplicity Easy P Soft Infusion Set for Infusion And/Or Injection of Fluids Into the…FPA · Abbreviated | 05/21/2002SE |
| K021487 | Simplicity Easy Access P Infusion SetFPA · Abbreviated | 05/17/2002SE |
| K021296 | Simplicity QD Easy P Infusion SetFPA · Abbreviated | 05/14/2002SE |
| K021216 | Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion PumpsFPA · Abbreviated | 05/03/2002SE |
| K021005 | Simplicity Easy Access II Infusion Set for Infusion And/Or Injection of Fluids Into the…FPA · Abbreviated | 04/25/2002SE |
| K020990 | Simplicity Soft QD II Infusion Set for Infusion And/Or Injection of Fluids Into the Body…FPA · Special | 04/10/2002SE |
| K020912 | Simplicity Easy Soft Infusion SetFPA · Abbreviated | 04/10/2002SE |
| K020629 | Simplicity Simplex Soft Infusion SetFPA · Abbreviated | 04/01/2002SE |
| K014062 | Simplicity Easy Access Infusion SetFPA · Abbreviated | 01/17/2002SE |
| K014061 | Simplicity Starplus Soft Infusion SetFPA · Abbreviated | 01/17/2002SE |
Questions and answers
When was Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump cleared by the FDA?
Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump (K013767) received a 510(k) decision of Substantially Equivalent on December 12, 2001, 29 days after the submission was received.
What is the product code of K013767?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.